Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 626-424-1 | CAS number: 59572-10-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)
- EC Number:
- 626-424-1
- Cas Number:
- 59572-10-0
- Molecular formula:
- C16H16O12S4.4Na
- IUPAC Name:
- 1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: the human epidermis
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: Dulbecco’s phosphate buffered saline (DPBS)
- Details on test system:
- The test system (non-transformed human-derived epidermal keratinocytes cultured to form a complex model of the human epidermis) was validated and approved by regulatory authorities for evaluation of skin irritation potential. The EpiDerm™ SIT was developed and designed to predict skin irritation potential of neat test substances in the context of identification and classification of skin irritation hazard according to the EU classification system (R 38 or no label).
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 44 hours+3 hours
- Number of replicates:
- 9
Test animals
- Species:
- other: human-derived epidermal keratinocytes
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 60 minutes
- Number of animals:
- 9
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- PTSA
- Value:
- 93.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: PTSA meets the requirement for UN GHS Category: No Category.
- Conclusions:
- Under the conditions of this study, PTSA is considered a non-irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
